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IRB-HSR > Managing Protocol After Initial Approval > Post Approval Monitoring

 

 

 

 

 

 

Post Approval Monitoring

Introduction

The Post Approval Monitoring and Education program has three goals:

  • Enhance protection of research subjects
  • Enhance quality of research data
  • Enhancement of the education program

Post-approval monitoring is done by staff within the office of the Vice President for Research and Graduate Studies (VPRGS) in accordance with their Standard Operating Procedures.

The VPRGS Post Approval Monitor(s) will attend IRB meetings to provide feedback to the IRB members.

The reason(s) for on-site review may include:

  • random selections,
  • complex projects involving unusual levels or types of risks to subjects,
  • projects conducted by an investigator who previously failed to comply with IRB determinations, or
  • projects where continuing review or reports from other sources have indicated that changes without IRB approval may have occurred or subjects were consented inappropriately,
  • HIPAA non-compliance,
  • subject or whistleblower complaints, or
  • a request by an IRB member and with approval by the IRB.

Full reports will be submitted to the IRB post approval monitoring sub-committee on a monthly basis. Aggregate summaries of the reports will be submitted to the full membership of the IRB on a quarterly basis. Information from the reports will also be reviewed by staff of the IRB the IRB Education Coordinator and the School of Medicine Clinical Trials Office for purposes of education updates.

Post Approval Monitoring Process

The conduct of an on-site review may include but is not limited to:

  • requests for progress reports from investigators,
  • examinations of research records, including signed informed consent documents, protocol modifications, and unexpected, serious, and/or related adverse experience reports,
  • contacts with research subjects, or
  • observation of the consent process and/or research procedures.

A written record of auditing activities is maintained in the study file and in the AVPRGS office. Any of the following may occur as a result of a monitoring report:

  • Possible actions the IRB may take include:
  • Recommendation to implement corrective actions
  • Request the post approval monitors review all active protocols of Principal Investigator
  • Request subsequent post-approval monitoring visits
  • Investigators to attend educational seminar
  • Suspension of subject enrollment
  • Suspension (protocol closed to treatment)
  • Termination of IRB-HSR approval ( protocol closed)
  • Require protocol to be re-audited at specific time/ enrollment period
  • Require PI to be mentored for a specific period of time
  • Replacement of PI
  • Disallow PI to conduct research for a period of time
  • Require PI to notify subjects of non-compliance and get their permission to publish the data
  • Notification of chair, dean, and research ethics committee
  • Require PI to inform journals of noncompliance when submitting for publication
  • Reporting of non-Compliance to federal agencies ( required if suspension or termination occurred)
  • Notification of all investigators at institution via education programs to ensure all are aware of regulations, so the noncompliance would be less likely to happen again.
  • If noncompliance put subjects at risk, may request a "peer review"
  • Consult with OHRP regarding appropriate corrective action

If there are concerns regarding scientific misconduct such as fraud or IRS issues, notify the UVA Research Integrity Officer at 434-924-3606.

The monitoring report is reviewed at a convened meeting of the IRB.

When accepted by the IRB, the report findings and committee recommendations are forwarded to the principal investigator for response and resolution of any outstanding issues, the AVRPGS, and others, including federal regulatory agencies, as deemed necessary by the IRB.

Non-Compliance: Auditing for Cause

Information regarding non-compliance in human subjects studies may come to the attention of the IRB in several ways.

These include:

  • information contained in new applications,
  • continuing reviews,
  • adverse event reports, and
  • reports from collaborators, employees, the public, or subjects.

The chair of the appropriate IRB reviews allegations of non-compliance.

The chair makes a determination as to whether the alleged practices appear to

  • cause injury or any other unanticipated problems involving risks to subjects or others, or
  • constitute serious or continuing non-compliance with IRB determinations or federal regulations.

In such cases, the chair may suspend the study procedures pending a timely investigation and review by the full IRB.

At the discretion of the chair or board, a study may continue while minor incidents of noncompliance are under investigation. The chair may elect to discuss an allegation of noncompliance with the IRB prior to suspending the protocol if it is apparent that there is no increased risk to subjects.

The Chair and/or the AVPRGS, may suspend studies when:

  • the violation is a clear violation of the regulations,
  • a violation of university policy, or
  • there is imminent danger to subjects.

The chair and/or the IRB will confirm this action as soon as possible.

Allegations of Misconduct

Investigations by the IRB focus on the protection of study subjects. In cases that involve allegations of research misconduct, the chair contacts the University of Virginia Research Integrity Officer (RIO) for further action. This does not preclude the chair or any member of the IRB from independently contacting the RIO about any allegation of research misconduct. Inquiries or investigations into research misconduct do not preclude IRB review and actions.

The conduct of an on-site review may include:

  • requests for progress reports from investigators,
  • examinations of research records, including signed informed consent documents, protocol modifications, and serious and/or adverse experience reports,
  • contacts with research subjects, or
  • observation of the consent process.

Examples of when observation of the consent process could occur are:

  • the full board IRB determines during review of a project that a conflict of interest exists such that the informed consent process should be observed by a neutral party;
  • the IRB is made aware of a complaint or concern with regard to the informed consent process; or
  • the IRB determines as a result of the monitoring process that the consent process is insufficient and education/training is required for conduct of consent.

The following are the recommended procedures for resolving alleged non-compliance:

  • When made aware of a potential problem, AVPRGS staff compiles file information and presents concerns to the appropriate IRB chair or incorporates the findings into the continuing review summary presented to the IRB.
  • The chair makes a determination to refer the matter to the Post Approval Monitor to contact the principal investigator. The purpose of such contact is fact-finding, i.e., to determine whether the problem is intentional, unintentional and/or the result of mistake or oversight.
  • The chair may temporarily halt enrollment and/or data collection until full board review occurs (with consideration of effect in therapeutic trials). However, when an audit is recommended based on the consents or authorizations submitted with the progress report and the chair has determined there is no increased risk to the subjects; the study may continue and no corrective action will be required by the researchers until the audit is accepted by the IRB.
  • The IRB Director or designee, at the direction of the chair, documents the outcome of any and all communications and discussions in writing, by either e-mail or paper memo with a copy to the IRB files. Such documentation should be factual and objective.
  • When the initial inquiry does not result in resolution of the matter, a meeting with the principal investigator is scheduled as soon as possible. A member of the IRB staff documents results of the meeting.
  • Any discussions, findings, efforts to achieve resolution and sanction recommendations are documented at the next IRB meeting by the chair or IRB Research Compliance Monitor. The IRB is granted authority to recommend sanctions to the Research Compliance Monitor.
  • At a convened meeting, a quorum of IRB members will discuss the findings, recommend actions, and vote to approve the recommended actions.
  • The IRB has the authority to suspend or terminate IRB approval of protocols that are found to be non-compliant with institutional policies and procedures, state statutes, and/or federal laws or regulations.
  • The AVPRGS sends written notification of actions taken to the principal investigator with copies to the departmental chair, AVPRGS and the research offices of other affiliated institutions, as determined by the IRB. To the extent that any action includes suspension or termination, in cases of externally funded programs, notice will be sent to the Office of Grants Management or the Office of Industry Contracts. Federal regulatory agencies are notified of actions as required by federal regulation.

*Taken from UVa IRB-HSR Research Guidance